Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity

NCT03650374 | Completed

• 1 other identifier: 18-01100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity. After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.

Conditions

Meniscus; Detachment, Current Injury

Keywords

Meniscus root tear

Outcome Measures

Primary Outcomes (1)

• KOOS

  A patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.

  6 Weeks, 3 Months, 6 Months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

standard of care postoperative rehabilitation.

Other: Standard of Care Rehabilitation

Group 2

EXPERIMENTAL

experimental strength training

Other: Experimental Strength Training

Interventions

Standard of Care Rehabilitation OTHER

Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.

Group 1

Experimental Strength Training OTHER

Will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is indicated for meniscal root repair
• Patient is indicated for meniscus transplant
• Patient is at least 18 years of age
• Patient is expected to survive at least 1 year beyond surgery
• Patient has intact lower extremities bilaterally
• Patient is willing to participate by complying with pre-and post-operative visit requirements
• Patient is willing and able to review and sign a study informed consent form

You may not qualify if:

• Lower extremity musculoskeletal defects
• Systemic neuromuscular disorders
• Failure to complete pre-operative BIDOEX strength assessment
• Failure to complete pre-operative self-assessment score intake forms

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Guillem Gonzalez-Lomas, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 28, 2018
• Study Start: September 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)